Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The study was conducted at 5 international sites – Ghana, Kenya, Mali, Bangladesh, and Vietnam from 29 March 2007 (first patient in) to 13 October 2008 (last dose given).

Last subject completed follow-up: 31 March 2009

All data corrections applied (Frozen File): 20 July 2009

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Excluded from the trial before assignment to groups were subjects: with history of active gastrointestinal illness (vomiting, diarrhea, elevated temperature); who were participating in (or expected to participate in) other investigational-product studies; who could not be followed adequately for safety.

Reporting Groups

Description

RotaTeq™ - Africa

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

Placebo - Africa

Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

RotaTeq™ - Asia

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

Placebo - Asia

Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

Participant Flow: Overall Study

RotaTeq™ - Africa

Placebo - Africa

RotaTeq™ - Asia

Placebo - Asia

STARTED

2733
[1]

2735
[1]

1018
[1]

1018
[1]

Vaccinated at Visit 1

2733

2735

1018

1018

Vaccinated at Visit 2

2657

2666

1013

1009

Vaccinated at Visit 3

2613

2612

1009

1007

COMPLETED

2607
[2]

2601
[2]

1009
[2]

1007
[2]

NOT COMPLETED

126

134

9

11

Adverse Event

12

21

1

0

Lost to Follow-up

62

69

4

3

Protocol Violation

4

2

2

2

Withdrawal by Subject

48

42

2

6

[1]

Subjects who passed all entry criteria and who were randomized in to the study

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

RotaTeq™ - Africa

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

Placebo - Africa

Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

RotaTeq™ - Asia

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

Placebo - Asia

Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination.

Additional Description

For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.

Frequency Threshold

Threshold above which other adverse events are reported

0%

Reporting Groups

Description

RotaTeq™

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).

Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination.

Placebo

Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).

Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination.

RotaTeq™, Placebo, RotaTeq™

Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.

Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination.

Placebo, Placebo, RotaTeq™

Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.

Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination.

RotaTeq™ - Kenya Safety Cohort

A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.

Placebo - Kenya Safety Cohort

A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.